System for and method of treating aneurysms

ABSTRACT

An apparatus for treating an aneurysm in a blood vessel includes a wire to be advanced within a tube and an occlusion element disposed on the wire. The occlusion element includes a cover and an inner anchoring member. The occlusion element is configured to fit within the tube and slide out of an opening at distal end of the tube in response to movement of the wire. The cover is configured to expand to an expanded configuration when advanced into the aneurysm, wherein the cover comprises a diameter that is greater than the diameter of a neck portion of the aneurysm and is configured such that a first portion of the cover contacts an interior surface of the aneurysm and a second portion covers the neck portion of the aneurysm. The inner anchoring member extends from the cover portion and is configured to contact the interior surface of the aneurysm.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Se. No.15/675,255, filed on Aug. 11, 2017, which is a continuation ofInternational Application No. PCT/US2016/019135, filed on Feb. 23, 2016,which claims priority to and the benefit of U.S. application Ser. No.62/120,456, filed on Feb. 25, 2015, each of which is incorporated hereinby reference in its entirety.

BACKGROUND

Aneurysms are abnormal bulging or weakening of a blood vessel, often anartery, and can have many complications. A bulging of the blood vesselcan disrupt or put pressure on surrounding tissues. In the brain, thiscan result in a variety of side effects, such as impaired vision,impaired speech, impaired balance, etc. Further, the aneurysm creates avolume that is not along the main flow path of the blood through theblood vessel. It therefore can serve as a location for blood to becomestagnant and, due to swirling eddy currents, can contribute to theformation of a thromboembolism. If the aneurysm ruptures, they can causesevere internal bleeding.

Aneurysms can be treated externally with open surgery. Such procedurestypically involve closing off the entrance or “neck” of the aneurysmwith a device such as vascular clamp or a ligature. However, such opensurgical procedures can be highly invasive and may lead to trauma to theadjacent tissue and other side effects.

Aneurysms can also be treated through endovascular procedures. In oneprocedure, detachable lengths of wires (e.g., coils) are inserted intothe interior volume of the aneurysm using a catheter. The coils areintended to fill the volume of the aneurysm to decrease the flow ofblood into the aneurysm, inducing stagnation of flow and stimulateclotting within the aneurysm. In settings of large cerebral aneurysms,filling of the aneurysm with multiple coils can lead to mass effect thatmay induce brain swelling and be an independent cause for new symptoms.In another procedure, for aneurysms with a relatively large neck, theadjunctive use of stents assists with the retention of the coils withinthe aneurysm. This approach has a contraindication to being used whentreating ruptured aneurysm, due to the need for additionalanti-thrombotic medications. In another procedure, the coils are held inthe volume of the aneurysm with a temporary balloon that is inflated inthe blood vessel. The balloon is deflated and removed once the mass ofcoils is secured. In still another procedure, a stent device is placedin the artery to promote flow of blood past the aneurysm. This leads tostagnation of the blood within the aneurysm and thrombosis inside theaneurysm volume. However, a side branch of a main artery in which thestent device is placed may become trapped or “jailed”, which impedesaccess to the side branch. In other instances, the side branch canbecome clotted off, possibly causing a stroke. Additionally, such aprocedure generally requires the use additional anti-thromboticmedications, which limits the use of such devices in the setting oftreatment of ruptured aneurysms. The stent device is generally formedwith a relatively tight weave. While the tight weave increases theeffectiveness of the stent device in diverting the blood flow, it alsoimpedes or prevents access to the volume of the aneurysm or the jailedartery. In the event that the aneurysm fails to clot, the obstruction ofthe aneurysm by the stent device prevents the possibility of placingembolic devices inside the aneurysm. Additional procedures such as theplacement of additional stents or open surgery may then be required totreat the residual.

All procedures that involve packing the volume of the aneurysm sufferfrom several common shortcomings. First, it can take many coils of wireto fill the volume of the aneurysm, which is time consuming andincreases the time it takes to complete the procedure. Further, thecoils may be compacted over time to occupy a smaller percentage of thetotal volume of the aneurysm. A great enough compaction of the coils canbe considered a recurrence of the aneurysm and may require furthertreatment.

It would be advantageous to provide an improved system and method oftreating an aneurysm.

SUMMARY

One embodiment relates to a catheter for treating an aneurysm in a bloodvessel. The catheter includes a tube, a wire disposed within the tube;and an occlusion element. The occlusion element is disposed on the wire.The occlusion element is configured to fit within the tube and slide outof an opening at distal end of the tube in response to movement of thewire within the tube. The occlusion element is configured to expand tohave a radius greater than a radius of the tube and cover a neck portionof the aneurysm.

One embodiment relates to a method treating an aneurysm in a bloodvessel. The method includes providing a distal portion of a tube to aneck region of the aneurysm, and sliding a wire attached to an occlusionelement within the tube so that the occlusion element exits the tube atthe neck region. The method also includes separating the occlusionelement from the wire after the occlusion element exits the tube.

One embodiment relates to an occlusion system for treating an aneurysmin a blood vessel. The occlusion system includes a wire, and anocclusion element disposed on the wire. The occlusion element isconfigured to be compressed in a conical shape and expand in a disk orconcave shape for covering a neck portion of the aneurysm.

The invention is capable of other embodiments and of being practiced orbeing carried out in various ways. Alternative exemplary embodimentsrelate to other features and combinations of features as may begenerally recited in the claims.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other features, aspects and advantages of the presentinvention will become apparent from the following description, appendedclaims, and the accompanying exemplary embodiments shown in thedrawings, which are briefly described below.

FIG. 1 is a schematic cross-section side view of an aneurysm with anendovascular device configured to occlude the aneurysm, according to anexemplary embodiment.

FIG. 2 is schematic cross-sectional bottom view of the aneurysmocclusion device of FIG. 1.

FIGS. 3A-3E are schematic side cross-section views of a catheterdeploying the aneurysm occlusion device of FIG. 1, according to anexemplary embodiment.

FIG. 4 is a schematic cross-section side view of an aneurysm with anendovascular device configured to occlude the aneurysm, according toanother exemplary embodiment.

FIG. 5 is a schematic cross-section view of the occlusion device of FIG.4 inside of a catheter, according to an exemplary embodiment.

FIG. 6 is a schematic cross-section side view of an aneurysm with anendovascular device configured to occlude the aneurysm, according toanother exemplary embodiment.

FIG. 7 is a schematic cross-section side view of an aneurysm with anendovascular device configured to occlude the aneurysm, according toanother exemplary embodiment.

FIG. 8 is a schematic cross-section side view of an aneurysm with anendovascular device configured to occlude the aneurysm, according toanother exemplary embodiment.

FIG. 9 is a schematic cross-section side view of an aneurysm with anendovascular device configured to occlude the aneurysm, according toanother exemplary embodiment.

FIG. 10 is a schematic cross-section view of the occlusion device ofFIG. 7 inside of a catheter, according to an exemplary embodiment.

FIG. 11 is a schematic cross-section side view of an aneurysm with anendovascular device configured to occlude the aneurysm, according toanother exemplary embodiment.

FIG. 12 is a schematic cross-sectional bottom view of an aneurysmocclusion device, according to an exemplary embodiment.

FIG. 13 is a schematic cross-sectional bottom view of an aneurysmocclusion device, according to an exemplary embodiment.

FIG. 14 is a schematic cross-sectional bottom view of an aneurysmocclusion device, according to an exemplary embodiment.

FIG. 15 is a schematic cross-sectional side view of an aneurysm with anendovascular device configured to occlude the aneurysm, according toanother exemplary embodiment.

FIG. 16 is a schematic cross-sectional side view of an aneurysm with anendovascular device configured to occlude the aneurysm, according toanother exemplary embodiment.

FIG. 17 is a schematic bottom view of an outer anchoring member for ananeurysm occlusion device, according to an exemplary embodiment.

FIG. 18A is a schematic top view of a cover for an aneurysm occlusiondevice, according to an exemplary embodiment.

FIG. 18B is a schematic side view of the cover of FIG. 18A in apartially folded configuration.

FIG. 19 is a schematic side view of an endovascular device configured toocclude an aneurysm, according to another exemplary embodiment.

FIG. 20 is a schematic cross-sectional side view of an aneurysm with anendovascular device configured to occlude the aneurysm, according toanother exemplary embodiment.

DETAILED DESCRIPTION

Referring in general to FIGS. 1-14, an aneurysm occlusion deviceconfigured to treat an aneurysm 10 is shown according to severalexemplary embodiments. The aneurysm 10 is an outwardly extending bulgein the wall 13 of a blood vessel 12 and has an internal volume 14 thatis in fluid communication with the blood vessel 12 through an opening ata neck portion 16. The aneurysm 10 may occur at a portion of the bloodvessel 12 at which the wall 13 is weakened by disease or trauma. In oneembodiment, the aneurysm 10 may be along an artery, such as a cranialartery (e.g., e.g., basilar artery, middle cerebral artery, etc.). Theaneurysm 10, as depicted in the figures is exemplary only and it shouldbe appreciated that the occlusion devices as described herein may beutilized in the treatment of aneurysms of various sizes and locations.For example, the aneurysm 10 may be located between two branches of ablood vessel.

Referring to FIGS. 1-3E, an occlusion device 20 is shown according toone exemplary embodiment disposed in the neck portion 16 of the aneurysm10 to disrupt or halt the flow of blood flow between the vessel 12 andthe internal volume 14 of the aneurysm, thereby reducing the likelihoodthat the aneurysm 10 will rupture. The occlusion device 20 is configuredto be low profile device, minimizing disruptions to surrounding bodies,such as a side branch 18 of the blood vessel 12. The occlusion device 20may be configured to be biodegradable or bioabsorbable material and maybe configured to promote endothelialization.

The occlusion device 20 includes an inner cover 22 (e.g., plate,membrane, etc.) disposed within the internal volume 14 of the aneurysm10. The inner cover 22 has an outer diameter that is greater than thediameter of the neck portion 16. The inner cover 22 is a thin, flexible,concave body that can be distorted (e.g., collapsed) to be insertedthrough the neck portion 16 into the internal volume 14 of the aneurysm10 (e.g., inserted by a catheter) and opened to at least partiallyocclude the neck portion 16. Concave, as used herein, is meant todescribe any body that is contoured to have a hollow or cavity along oneside. As shown in FIG. 1, in one exemplary embodiment, the inner cover22 may be generally dome-shaped. In another embodiment, the inner cover22 may have another concave shape (e.g., conical) that is disposed inthe neck portion 16 and opens into the internal volume 14. In oneembodiment, cover 22 can be disk shaped.

The inner cover 22 is formed from a flexible (e.g., soft) biocompatiblematerial that can be collapsed into a microcatheter for endovasculardelivery to the aneurysm 10. The flexibility of the inner cover 22allows it to conform to the shape of the interior surface 15 of theaneurysm 10 and more effectively impeded the flow of blood between theaneurysm 10 and the blood vessel 12. Closely conforming to the shape ofthe interior surface 15 of the aneurysm 10 also facilitates the adhesionof the inner cover 22 to the tissue of the aneurysm 10 and the formationof new tissue to close off the neck portion 16.

The inner cover 22 may be sized to fit a specific aneurysm 10. As shownin FIGS. 1-2, the inner cover 22 has a diameter that is greater than thediameter of the neck portion 16 such that a peripheral portion 24 of theinner cover 22 contacts the interior surface 15 of the aneurysm 10. Theflexibility of the inner cover 22 allows the inner cover 22 to beoversized relative to the size of the neck portion 16 without damaging(e.g., rupturing) the aneurysm 10. For example, an inner cover having adiameter of approximately 5 mm may be utilized to occlude an aneurysmhaving a neck portion with a diameter of up to 4 mm; an inner coverhaving a diameter of approximately 8 mm may be utilized to occlude ananeurysm having a neck portion with a diameter of 4-6 mm; and an innercover having a diameter of approximately 12 mm may be utilized toocclude an aneurysm having a neck portion with a diameter of 6-10 mm.

In one embodiment, the inner cover 22 may be formed from a biocompatiblemetal or metal alloy, such as platinum, stainless steel, titanium, atitanium-nickel alloy (e.g., nitinol). For example, the inner cover 22may be a concave disk formed from sheet-cut nitinol. The nitinol alloymay be configured to undergo a secondary heat setting to form thedesired concave shape. According to an exemplary embodiment, the innercover 22 may have a thickness of less than 100 microns, to achieve adesired flexibility. In another embodiment, the inner cover 22 may beformed as a relatively dense mesh such as 37 micron mesh formed by aplurality of wires or fibers that are coupled together (e.g., welded,soldered, woven, etc.).

In another embodiment, the inner cover 22 may be formed from abiocompatible polymer, such as polytetrafluoroethylene (PTFE), modifiedpolyurethane, silicone or other suitable polymer. In still otherexemplary embodiments, the inner cover 22 may be formed from a metal oralloy that is coated with a polymer (e.g., parylene, PTFE, PFE, etc.) toincrease lubricity and biocompatibility and to reduce thrombogenicity.The inner cover 22 may be formed as a solid sheet or membrane or may bea relatively dense mesh. In some embodiments, the inner cover 22 mayinclude laser drilled nylon sheeting to provide a matrix forendothelialization, while reducing the bulk of the segment. Anotherembodiment may involve two photon polymerization, or 3-D printing of abiocompatible material to form the inner cover 22 directly onto thedelivery system, or to overlie a skeleton frame which is attached to thedelivery system, allowing customization of the final shape of the innercover 22 at the time of treatment.

Referring now to FIGS. 3A-3D, the inner cover 22 is showing beingdeployed with a catheter 30 according to an exemplary embodiment.Referring to FIG. 3A, the catheter 30 including a push wire 32 isadvanced through the blood vessel 12 to the location of the aneurysm 10.A distal end 34 of the catheter is advanced through the neck portion 16and into the internal volume 14 of the aneurysm 10 or to the portion ofthe blood vessel 12 proximate the neck portion 16. The push wire 32 ispositioned within a lumen formed in the catheter 30. The catheter 30 mayhave a single lumen or the push wire 32 may be positioned within one ofseveral lumens formed within the catheter 30. The inner cover 22 iscoupled to a distal end 36 of the push wire 32 and is housed, in acollapsed configuration, within the lumen. In the collapsedconfiguration, the peripheral portion 24 of the inner cover 22 isupstream (e.g., closer to the distal end 34) compared to a centralportion 26 to which the push wire 36 is coupled. Referring to FIG. 3B,the push wire 32 is moved within the lumen relative to the catheter 30until the inner cover 22 begins to emerge from the end 34 of thecatheter 30. The inner cover 22 is configured to expand (e.g., due tothe internal spring forces of the inner cover 22) into an expandedconfiguration within the internal volume 14 as it clears the end 34 ofthe catheter 30. The push wire 32 may be moved relative to the catheter30 by holding the catheter 30 stationary while the push wire 32 isadvanced (e.g., pushing), by holding the push wire 32 stationary andretracting the catheter 30 (e.g., unsheathing), or by a combination ofmovements of the catheter 30 and the push wire 32. The inner cover 22may be partially deployed with the distal end 34 of the catheter 30positioned within the blood vessel 12 or within the aneurysm 10.

Referring to FIG. 3C, the distal end 34 of the catheter 30 is advancedinto the internal volume 14 of the aneurysm 10 before the inner cover 22is fully deployed from the catheter 30. Referring to FIG. 3D, with theinner cover 22 deployed from the catheter 30, the catheter 30 and/or thepush wire 32 is retracted until the inner cover 22 is seated against theinterior surface 15 of the aneurysm. Referring to FIG. 3E, the distalend 36 of the push wire 32 is detached from the inner cover 22 such thatthe catheter 30 and the push wire 32 may be withdrawn from the bloodvessel 12 while the inner cover 22 remains in the neck portion 16 of theaneurysm 10. The push wire 32 may be detached from the inner cover 22 byany suitable electrical or mechanical cutting device. Alternatively, theinner cover 22 can be removed by pulling the wire 32 from cover 22causing cover 22 to engage distal end of tube 30 and be slid off wire32.

In one embodiment, the inner cover 32 can be formed to be biased towardthe open position. In another embodiment, the inner cover 32 can includea mesh supported by rib members or splines radiating outwardly form acenter of inner cover 32. The rib members or splines are biased towardan open position in one embodiment. In one embodiment, the rib membersand splines operate in an upside down umbrella operation fashion andlock in the fully open position once the fully open position is reached.

Referring now to FIG. 4-5, an occlusion device 120 is shown according toan exemplary embodiment disposed in the neck portion 16 of the aneurysm10 to disrupt or halt the flow of blood flow between the vessel 12 andthe internal volume 14 of the aneurysm, thereby reducing the likelihoodthat the aneurysm 10 will rupture. The occlusion device 120 isconfigured to be low profile device, minimizing disruptions tosurrounding bodies, such as a side branch 18 of the blood vessel 12. Theocclusion device 120 may be configured to be biodegradable orbioabsorbable material and may be configured to promoteendothelialization.

The occlusion device 120 includes an inner cover 122 (e.g., plate,membrane, etc.) disposed within the internal volume 14 of the aneurysm10 and similar to the inner cover 22 described above. The occlusiondevice 120 further includes an inner anchoring member 140 disposedwithin the aneurysm 10. The inner anchoring member 140 is configured toanchor the inner cover 122 within the aneurysm 10 in the neck portion16. The inner anchoring member 140 provides a relatively rigid body thatsupports the inner cover 122 and reduces the likelihood that the innercover 122 will be displaced from the neck portion 14 by the fluidpressure of the blood in the blood vessel 12.

According to an exemplary embodiment, the inner anchoring member 140includes one or more loops of a coil formed from a suitablebiocompatible metal or alloy (e.g., platinum, stainless steel,nickel-titanium alloy, etc.). The metal coil may be similar to the coilsthat are typically utilized in an endovascular coiling procedure. Theinner anchoring member 140 is coupled to the inner cover 122 andincludes at least one coil that contacts the interior surface 15 of theaneurysm 10. The loops of the inner anchoring member 140 do not fill theentire internal volume 14 or a substantial portion of the internalvolume 14. Instead, the inner anchoring member 140 may include only asmall number of loops. In one exemplary embodiment, the inner anchoringmember 140 may include a single loop of the coil. In another embodiment,the anchoring member 140 includes a large number of loops substantiallyfiling the internal volume 14. The orientation, number, and size of theloops of the inner anchoring member 140 may vary depending on the sizeand shape of the aneurysm 10.

Referring now to FIG. 5, the inner cover 122 and the inner anchoringmember 140 are shown disposed within a catheter 30 according to anexemplary embodiment. The inner cover 122 is coupled to a distal end 36of the push wire 32 and is housed, in a collapsed configuration, withinthe lumen of the catheter 30. In the collapsed configuration, theperipheral portion 124 of the inner cover 122 is upstream (e.g., closerto the distal end 34) compared to a central portion 126 to which thepush wire 36 is coupled on a first surface 144. The inner anchoringmember 140 is coupled to a second surface 146 of the inner cover 122opposite the first surface 142 and is disposed within the lumen of thecatheter 30 upstream of the inner cover 122.

The occlusion device 120 including the inner cover 122 and the inneranchoring member 130 is deployed within the aneurysm 10 similar to theprocess described above with reference to FIGS. 3A-3E. With the distalend 34 of the catheter 30 positioned proximate to the neck portion 16 ofthe aneurysm 10, the push wire 32 is moved within the lumen relative tothe catheter 30. The push wire is moved to cause the anchoring member 40to reach the internal volume 14 and coil within the internal volume.

In one embodiment, the push wire 32 has a circular solid cross sectionand anchoring member 140 has a coiled cross section (e.g., like atelephone cord) to facilitate coiling in the internal volume 14. In oneembodiment, the push wire 32 and the anchoring member 140 have acircular solid cross section. In one embodiment, the push wire 32 andanchoring member have a coiled solid cross section.

After coiling of the anchoring member is complete, the inner anchoringmember 140 is pushed out of the catheter and into the internal volume14, where is contacts the interior surface 15 of the aneurysm 10. Thepush wire 32 is moved further until the inner cover 122 begins to emergefrom the end 34 of the catheter 30 to expand into an expandedconfiguration within the internal volume 14. The catheter 30 and/or thepush wire 32 is then retracted until the inner cover 122 is seatedagainst the interior surface 15 of the aneurysm 10 and held in place bythe inner anchoring member 140. The distal end 36 of the push wire 32 isdetached from the first surface 146 of the inner cover 122 such that thecatheter 30 and the push wire 32 may be withdrawn from the blood vessel12 while the inner cover 22 remains in the neck portion 16 of theaneurysm 10 with the inner anchoring member 140 coupled to the secondsurface 146.

Referring to FIG. 6, in one exemplary embodiment, the anchoring member140 may have a variable stiffness. For example, the inner anchoringmember 140 may be relatively pliable at a proximal end 146 andrelatively stiff at a distal end 148. The relatively stiff distal end146 may be configured to provide additional support to strengthen thewalls of the aneurysm 10. The stiffer portions of the inner anchoringmember 140 may be utilized as framing members to create a structure inthe internal volume 14 of the aneurysm while the more pliant portionsare utilized to fill in the internal volume of the aneurysm and supportthe inner cover 122. The stiffness of the inner anchoring member 140 maybe controlled in a variety of ways, such as by varying the thickness ofthe coil, the radius of the coil, and/or by varying the material used toform the coil.

The more pliant portions of the inner anchoring member may include aremovable sheathe or layer to facilitate the positioning of the stifferportions of the inner portions of the anchoring member 140 within theaneurysm 10. The sheathe may be removed once the distal end 148 and thestiffer portions of the inner anchoring member 140 are positioned.

In one embodiment, the stiffness of the inner anchoring member 140 maytransition smoothly or incrementally along the length of the inneranchoring member 140 between the distal end 148 and the proximal end146. In other exemplary embodiments, the inner anchoring member 140 mayinclude two or more distinct zones or portions, each with a differentstiffness or other characteristic. The inner anchoring member 140 mayinclude markers or other indicators to delineate the transition from onezone to another. In one embodiment, the indicators may be external, suchas indicators provided on an outer shaft coupled to the push wire, eachof the outer indicators corresponding to the transition from a zone witha first stiffness to a zone with a second stiffness. In anotherembodiment, the indicators may be internal, such as radiopaqueindicators (e.g., a platinum coating) on the inner anchoring member 140between the zones.

In one embodiment, the anchoring member 140 with a variable stiffnesscan be utilized without the inner cover 122. In such an embodiment, theanchoring member 140 fills the internal volume 14. In one embodiment, anumber of anchoring members 140 can be utilized. In one embodiment, thefirst employed anchoring member 140 has a varying stiffness (e.g.,thickness) that is greater than the varying stiffness (e.g., thickness)of the next employed anchoring member.

Referring now to FIG. 7-10, an occlusion device 220 is shown accordingto an exemplary embodiment disposed in the neck portion 26 of theaneurysm 20 to disrupt or halt the flow of blood flow between the vessel22 and the internal volume 24 of the aneurysm 20, thereby reducing thelikelihood that the aneurysm 20 will rupture. The occlusion device 220is configured to be low profile device, minimizing disruptions tosurrounding bodies, such as a side branch 28 of the blood vessel 22. Theocclusion device 220 may be configured to be biodegradable orbioabsorbable material and may be configured to promoteendothelialization.

The occlusion device 220 includes an inner cover 222 (e.g., plate,membrane, etc.) disposed within the internal volume 14 of the aneurysm10 and similar to the inner cover 22 described above and an inneranchoring member 240 disposed within the aneurysm 10 and similar to theinner anchoring member 140 described above. The inner anchoring member240 is configured to anchor the inner cover 222 within the aneurysm 20in the neck portion 16. The occlusion device 220 further includes anouter anchoring member 250 disposed in the within the blood vessel 12proximate the aneurysm 10. The outer anchoring member 250 provides arelatively rigid body that supports the inner cover 222 and reduces thelikelihood that the inner cover 222 will be displaced from the neckportion 14 by the fluid pressure of the blood in the blood vessel 12.

Referring to FIG. 7, according to an exemplary embodiment, the outeranchoring member 250 includes a loop 252 of a coil formed from asuitable biocompatible metal or alloy (e.g., platinum, stainless steel,nickel-titanium alloy, etc.). The metal coil may be similar to the coilsthat are typically utilized in an endovascular coiling procedure. Theloops 252 is coupled to the inner cover 222 and contacts the wall 13 ofthe blood vessel 12 in one embodiment. The loop 252 is orientedperpendicular to the flow of blood through the blood vessel 12 in oneembodiment. Multiple coils or loops 252 can be utilized in oneembodiment.

Referring to FIG. 8, according to an exemplary embodiment, the outeranchoring member 250 includes a first loop 254 and a second loop 256.The loops 254 and 256 may be loops of a coil formed from a suitablebiocompatible metal or alloy (e.g., platinum, stainless steel,nickel-titanium alloy, etc.). At least one of the loops 254 and 256 arecoupled to the inner cover 222 and contact the wall 13 of the bloodvessel 12. The first loop 254 extends about the inner circumference ofthe blood vessel 12 such that it is oriented perpendicular to the flowof blood through the blood vessel 12. The second loop 256 is orientedparallel to the flow of blood through the blood vessel 12. The secondloop 256 is formed of a coil having a fairly small diameter and does notsubstantially impede the flow of blood through the blood vessel. Inother embodiment, the outer anchoring member 250 may include more thantwo loops. The orientation, number, and size of the loops may varydepending on the size and shape of the blood vessel 12.

Referring to FIG. 9, according to another exemplary embodiment, theouter anchoring member 250 includes a stent 258 formed from a suitablebiocompatible metal or alloy (e.g., platinum, stainless steel,nickel-titanium alloy, etc.) or a suitable biocompatible polymer. Thestent 258 is introduced in a collapsed state to the blood vessel 12proximate the aneurysm 10 via the catheter 30. Once deployed into theblood vessel 12, the stent 258 is expanded to compress against the wallsof the blood vessel 12. The stent 258 may be self-expandable or may beexpanded with another device, such as an inflatable balloon. All or partof the stent 258 may be coated or covered with a radiopaque material,such as a platinum to allow for visualization of the stent 258 (e.g.,during and after the placement of the stent 258).

The stent 258 is not intended to occlude the neck portion 16 of theaneurysm 10, but instead forms a structure to facilitate the placementand anchoring of the inner cover 222. The stent 258 therefore does notneed to be as wide as or wider than the neck portion 16, but may be arelatively short body (e.g., shorter than the width of the neck portion16 of the aneurysm 10). The relatively short length of the stent 258reduces the likelihood that the outer anchoring member 250 will disruptsurrounding bodies, such as a side branch 18 of the blood vessel 12.Further, the stent 258 may have a non-dense, relatively openconfiguration with variable cell morphology which may extend proximallyin the blood vessel 12 from the neck portion 16. In other embodiments,the stent 258 may be a solid member, such as a band formed of a metal oralloy with a relatively thin thickness.

In another embodiment, the outer anchoring member 250 may be a temporarymember that is removed with the catheter 30 after the occlusion device320 has been placed in the neck portion 16 of the aneurysm and has beencoupled to the walls of the aneurysm 10. For example, the outeranchoring member may be a balloon that is inflated in the blood vessel12 proximate the aneurysm to provide a temporary structure to supportthe inner cover 222.

Referring now to FIG. 10, the inner cover 222, the inner anchoringmember 240, and the outer anchoring member 250 are shown disposed withina catheter 30 according to an exemplary embodiment. The outer anchoringmember 250 is coupled to a distal end 36 of the push wire 32 and ishoused, in a collapsed configuration, within the lumen of the catheter30. The outer anchoring member 250 is coupled to the inner cover 222,which is housed, in a collapsed configuration, within the lumen of thecatheter 30 upstream of the outer anchoring member 250. The outeranchoring member 250 may be coupled to the inner cover 222, for example,with an adhesive. In the collapsed configuration, a peripheral portion224 of the inner cover 222 is upstream of a central portion 226 to whichthe outer anchoring member 250 is coupled on a first surface 244. Theinner anchoring member 240 is coupled to a second surface 246 of theinner cover 222 opposite the first surface 242 and is disposed withinthe lumen of the catheter 30 upstream of the inner cover 222.

The occlusion device 220 including the inner cover 222 and the inneranchoring member 230 is deployed within the aneurysm 20 similar to theprocess described above with reference to FIGS. 3A-3E. With the distalend 34 of the catheter 30 positioned proximate to the neck portion 26 ofthe aneurysm 20, the push wire 32 is moved within the lumen relative tothe catheter 30. The inner anchoring member 240 is pushed out of thecatheter and into the internal volume 24, where is contacts the interiorsurface 25 of the aneurysm 20. The push wire 32 is moved further untilthe inner cover 222 begins to emerge from the end 34 of the catheter 30to expand into an expanded configuration within the internal volume 24.The catheter 30 and/or the push wire 32 is then retracted until theinner cover 222 is seated against the interior surface 25 of theaneurysm 20 and held in place by the inner anchoring member 240. Thepush wire 32 is moved further until the outer anchoring member 250emerges from the catheter 30. The outer anchoring member 250 may be, forexample, one or more loops 252, 254, or 256, or the stent 258. Thedistal end 36 of the push wire 32 is detached from the outer anchoringmember such that the catheter 30 and the push wire 32 may be withdrawnfrom the blood vessel 22 while the inner cover 22 remains in the neckportion 26 of the aneurysm 20 with the inner anchoring member 240coupled to the second surface 246 and the outer anchoring member 250disposed in the blood vessel 12. In other embodiments, the push wire 32may be coupled directly to the inner cover 222 and the outer anchoringmember 250 may be deployed separately (e.g., from another catheter).

Referring now to FIG. 11-14, an occlusion device 320 is shown accordingto an exemplary embodiment disposed in the neck portion 16 of theaneurysm 10 to disrupt or halt the flow of blood flow between the vessel12 and the internal volume 14 of the aneurysm, thereby reducing thelikelihood that the aneurysm 10 will rupture. The occlusion device 320is configured to be low profile device, minimizing disruptions tosurrounding bodies, such as a side branch 18 of the blood vessel 12. Theocclusion device 320 may be configured to be biodegradable orbioabsorbable material and may be configured to promoteendothelialization.

The occlusion device 320 includes an inner cover 322 (e.g., plate,membrane, etc.) disposed within the internal volume 14 of the aneurysm10 and similar to the inner cover 32 described above. The occlusiondevice 320 further includes an outer cover 360 disposed in the bloodvessel 12 proximate the aneurysm 10. The outer cover 360 may be coupledto the inner cover 322 provides a relatively rigid body to support theinner cover. The outer cover 360 reduces the likelihood that the innercover 322 will be displaced from the neck portion 34 by the fluidpressure of the blood in the blood vessel 32. The outer cover 360 may beutilized instead of or in addition to other devices, such as the inneranchoring member 140 or the outer anchoring member 250 to secure theinner cover 322 in the neck portion 16.

Referring to FIG. 11, according to an exemplary embodiment, the outercover 360 is a relatively thin member (e.g., plate, sheet, etc.) formedfrom a suitable biocompatible such as a metal or alloy (e.g., platinum,stainless steel, nickel-titanium alloy, etc.), or a polymer (e.g., PTFE,etc.). According to an exemplary embodiment, the outer cover 360 has athickness of less than 2 mm. According to a preferred embodiment, theouter cover has 360 has a thickness of less than 1 mm. The outer cover360 is a low-profile body that does not substantially impede the flow ofblood through the blood vessel 12. The outer cover 360 includes aperipheral portion 362 that contacts the wall 13 of the blood vessel 12around the neck portion 16 of the aneurysm 10 and a central portion 364disposed in the neck portion 16. The central portion 364 may beintegrally formed with the inner cover 322 or may be coupled to theinner cover 322 (e.g., with a suitable adhesive). All or part of theouter cover 360 may be coated or covered with a radiopaque material,such as a platinum, to allow for visualization of the outer cover 360(e.g., during and after the placement of the outer cover 360). Inembodiment, outer cover 360 is attached to inner cover at a center areahaving less area than the neck portion 16 (e.g., 90 percent, 75 percent,or 50 percent of the area of the neck portion). In one embodiment, thecenter area has a circular shape.

The outer cover 360 is not intended to occlude the neck portion 16 ofthe aneurysm 10, but instead forms a structure to facilitate anchor theinner cover 322. The outer cover 360 therefore does not need tocompletely cover the neck portion 16. The outer cover 360 may thereforebe shaped such that portions of the neck portion 160 are uncoveredand/or may be formed of a porous material (e.g., a mesh). Referring toFIG. 12, in one embodiment, the outer cover 360 may be a sheet thatcompletely covers the neck portion 16 such that the peripheral portion362 of the outer cover 360 extends about the entirety of the neckportion 16.

Referring to FIG. 13, in another embodiment, the outer cover 360 mayinclude multiple segments or sections such as radial lobes 366 thatextend outward from the neck portion 16. Each of the lobes 366 mayinclude a central portion 364 disposed within the neck portion 16 and aperipheral portion 364 extending beyond the neck portion 16 to contactthe wall 13 of the blood vessel 12.

Referring to FIG. 14, in another embodiment, the outer cover 360 mayinclude a spiral body 368. The inner loops of the spiral body 368 mayform the central portion 364 while the outer loops of the spiral body368 may form the peripheral portion 362.

The outer cover 360 may be deployed from a catheter in the sameprocedure as the inner cover 322. The outer cover 360 may therefore beconfigured to be collapsible such that it can be coupled to the innercover 322 and housed within the catheter. The outer cover 360 may beconfigured such that, within the catheter, the central portion 364 iscoupled to the inner cover 322 and positioned upstream of the peripheralportion 362. The inner cover 322 may be deployed as described withreference to FIGS. 3A-D. Once the inner cover 322 is deployed from thecatheter and positioned in the neck portion 16, the push wire of thecatheter may be advanced further to deploy the outer cover 360. Thefluid pressure of the blood within the blood vessel 12 forces the outercover 360 against the wall 13 of the blood vessel 12. In otherembodiments, the push wire 32 may be coupled directly to the inner cover322 and the outer cover 360 may be deployed separately (e.g., fromanother catheter).

Referring now to FIG. 15-16, an occlusion device 420 is shown accordingto an exemplary embodiment disposed in the neck portion 16 of theaneurysm 10. The occlusion device 420 includes an inner cover 422 (e.g.,plate, membrane, etc.) disposed within the internal volume 14 of theaneurysm 10. The occlusion device 420 further includes an inneranchoring member 440 disposed within the aneurysm 10 and/or an outeranchoring member 450. The inner anchoring member 440 is configured toanchor the inner cover 422 within the aneurysm 10 in the neck portion16. According to an exemplary embodiment, the inner anchoring member 440includes one or more struts or arms formed from a suitable biocompatiblemetal or alloy (e.g., platinum, stainless steel, nickel-titanium alloy,etc.). The inner anchoring member 440 is coupled to the inner cover 122and is configured to extend beyond the periphery of the inner cover 422to contacts the interior surface 15 of the aneurysm 10. The inneranchoring member 140 may therefore be used to facilitate the positioningof the inner cover 422 in an aneurysm 10 having a relatively wide neck16. The struts or arms of the inner anchoring member 140 do not fill theentire internal volume 14 or a substantial portion of the internalvolume 14. The “mass effect” of the aneurysm 10 is reduced, as the sizeof the aneurysm 10 is allowed to shrink as the vessel heals, therebyreducing the pressure placed on the surrounding tissue by the aneurysm.The orientation, number, and length of the arms of the inner anchoringmember 440 may vary depending on the size and shape of the aneurysm 10.The arms of the inner anchoring member 440 may be configured to collapsetogether to be delivered via a microcatheter, similar to themicrocatheter 30 described above.

Referring still to FIGS. 15-16, the outer anchoring member 450 includesfirst portion 452 (e.g., distal portion) disposed at the neck 16 andcoupled to the inner cover 420 and a second portion 454 (e.g., proximalportion) disposed in the vessel 12. The outer anchoring member 450 isformed from a suitable biocompatible metal or alloy (e.g., platinum,stainless steel, nickel-titanium alloy, etc.) or a suitablebiocompatible polymer. All or part of the outer anchoring member 450 maybe coated or covered with a radiopaque material, such as a platinum toallow for visualization of the outer anchoring member 450 (e.g., duringand after the placement of the outer anchoring member 450). The outeranchoring member 450 is introduced in a collapsed (e.g., straightened)state to the blood vessel 12 proximate the aneurysm 10 via a catheter.Once deployed into the blood vessel 12, the outer anchoring member 450expands such that at least a portion of the outer anchoring membercompresses against the walls of the blood vessel 12. The outer anchoringmember 450 may be formed as a single, continuous spiral, with loops ofthe spiral being formed to have variable properties (e.g., diameter,thickness, flexibility, etc.). For example, the first portion 452 may beformed to have relatively small diameter, flexible coils while thesecond portion 454 may be formed to have larger, relatively rigid coilsproviding an increased outward radial force to facilitate positioningthe outer anchoring member 450 along the wall 13 of the blood vessel 12.

Referring to FIG. 17, according to another exemplary embodiment, aportion of an outer anchoring member 460 may be formed as a dual spiral.According to other exemplary embodiments, the outer anchoring member maybe formed as a wide variety of other shapes (e.g., web-shaped,star-shaped, etc.) to provide a desired flexibility and support for theinner cover at the neck of the aneurysm.

Referring to FIGS. 18A-18B, according to another exemplary embodiment,an inner cover 470 for an occlusion device may be a star-shaped body.The inner cover 470 may be formed (e.g., creased, scored, molded) tofold and collapse along predefined fold lines.

Referring now to FIG. 19, an occlusion device 480 is shown having anouter anchoring member 482. The outer anchoring member 482 is arecapturable body that may be variously shaped (e.g., straight, spiral,multi-spiraled, coven, etc.). The outer anchoring member 482 is formedas a relatively open structure having a minimal number of segments thatform a framework that is capable of positioning and securing theocclusion device 480 while minimizing contact with the walls of theblood vessel. The open nature of the outer anchoring member 482 has alow risk of jailing a branch blood vessel or otherwise altering the flowof blood through the blood vessel.

Referring to FIG. 20, an inner anchoring member 494 for an occlusiondevice 490 is shown according to another exemplary embodiment. The inneranchoring member 494 includes a central wire 496 coupled to the cover492 and one or more outer wires 498 coupled to the central wire 496. Theouter wires 498 extend outward from the central wire 496 to contact theinterior surface 15 of the aneurysm 10. The inner anchoring member 494is introduced in a collapsed (e.g., straightened) state to the aneurysm10 via the catheter 30. Once deployed into the aneurysm 10, the catheter30 is withdrawn, allowing the outer wires 498 to expand outward suchthat at least a portion of the outer wires 298 contact the inner surface15 to position and anchor the cover 492 in the neck 16.

The construction and arrangement of the elements of the aneurysmocclusion device as shown in the various exemplary embodiments isillustrative only. Although only a few embodiments have been describedin detail in this disclosure, those skilled in the art who review thisdisclosure will readily appreciate that many modifications are possible(e.g., variations in sizes, dimensions, structures, shapes andproportions of the various elements, values of parameters, mountingarrangements, use of materials, colors, orientations, etc.) withoutmaterially departing from the novel teachings and advantages of thesubject matter recited herein. For example, elements shown as integrallyformed may be constructed of multiple parts or elements, the position ofelements may be reversed or otherwise varied, and the nature or numberof discrete elements or positions may be altered or varied. It should benoted that the elements and/or assemblies of the system may beconstructed from any of a wide variety of materials that providesufficient strength, durability, or biocompatibility. Othersubstitutions, modifications, changes and omissions may be made in thedesign, operating conditions and arrangement of the preferred and otherexemplary embodiments and medical procedures without departing from thescope of the present invention.

1-20. (canceled)
 21. An apparatus for treating an aneurysm in a bloodvessel, the apparatus comprising: an elongate push member; an occlusionelement coupled to a distal end of the push member and comprising aninner cover, the inner cover comprising a central portion configured tocover a neck portion of the aneurysm and a peripheral portion configuredto contact an interior surface of the aneurysm; an outer anchoringmember coupled to the inner cover and configured to be disposed withinthe blood vessel proximate the aneurysm and on the blood vessel side ofthe neck portion, the outer anchoring member comprising a plurality ofradial lobes extending from the central portion of the inner cover,wherein each of the plurality of radial lobes includes a central portionand a peripheral portion, the peripheral portion configured to extendbeyond the neck portion of the aneurysm; and wherein the inner cover andthe outer anchoring member are each configured to be collapsible foradvancement through a lumen of a catheter, and wherein the inner coverand the outer anchoring member are each configured to be expandable whendeployed from the lumen of the catheter.
 22. The apparatus of claim 21,wherein the plurality of radial lobes comprises at least three radiallobes.
 23. The apparatus of claim 22, wherein the plurality of radiallobes consists of three radial lobes.
 24. The apparatus of claim 22,wherein the at least three radial lobes are circumferentially arrayed ingenerally even manner.
 25. The apparatus of claim 21, wherein theperipheral portion of each of the plurality of radial lobes isconfigured to contact a wall of the blood vessel.
 26. The apparatus ofclaim 21, wherein the inner cover has a concave shape.
 27. The apparatusof claim 21, wherein the inner cover has a conical shape.
 28. Theapparatus of claim 21, wherein the inner cover is disk shaped.
 29. Theapparatus of claim 21, wherein the inner cover has a diameter of betweenabout 5 mm and about 12 mm.
 30. The apparatus of claim 21, wherein theinner cover has a thickness of less than 100 microns.
 31. The apparatusof claim 21, wherein the inner cover comprises a mesh of wires orfibers.
 32. The apparatus of claim 21, wherein the inner cover comprisesa metal.
 33. The apparatus of claim 21, wherein the inner covercomprises a nickel-titanium alloy.
 34. The apparatus of claim 21,wherein the inner cover comprises platinum.
 35. The apparatus of claim21, wherein the inner cover comprises a laser drilled sheet.
 36. Theapparatus of claim 21, wherein the push member comprises a wire.
 37. Theapparatus of claim 36, wherein the wire is configured to be mechanicallydetached from the inner cover.
 38. The apparatus of claim 36, whereinthe wire is configured to be electrically detached from the inner cover.39. The apparatus of claim 21, wherein the inner cover comprisessilicone.
 40. The apparatus of claim 21, wherein the inner covercomprises a 3-D printed material.